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Biotech / Medical : Pluristem Therapeutics
PSTI 8.720+0.2%Aug 14 5:00 PM EST
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From: FJB4/30/2013 8:36:18 AM
   of 295
 
Excerpt:

Surely United, like any pharma partner, recognizes the simplicity of human trials using PLX cells. United's Phase I Australian study will be done in only one center with varied doses, much like a Phase II yet requires just nine patients. There will be efficacy endpoints at six weeks after treatment to check patients' hearts and walking distance. Safety profiling is really just a regulatory formality (these are the ultimate biologics) but toxicity will be evaluated in a 12 month follow-up and considered a primary endpoint. Contrast this with Actelion's trial for Opsumit that was completed in December 2009 with a total of 742 patients, and is just now four years later up for FDA opinion.

Pluristem landed itself an attractive deal with United: an upfront payment of $7 million (almost as much as Gilead paid for the unlucky cicletanine) with milestones for another possible $48 million. United foots the clinical trial bill and if approved, PLX cells for PAH will be bought by United at a margin over whatever cost Pluristem bears, and a royalty will be paid on gross profits.

With Gilead out of the PAH picture, it was assumed that United and Pluristem would benefit, but who would have guessed United turns out to be its own worst clinical development enemy? Not only is a better drug essential for this disease that carries up to a 30% mortality rate, but I believe that United badly needs a new drug to keep, and expand, its PAH franchise.

seekingalpha.com
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